Quick Facts at a Glance
- Recall Date
- December 12, 2025
- Hazard Level
- HIGH
- Brand
- Elekta
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Elekta
- Product type
- Radionuclide RT Treatment Planning System
- Model numbers
- Lot Code: 07340048311236 (LGP 11.1)
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 12, 2025
Reported by FDA DEVICE
February 18, 2026
RecallRadar source check
April 13, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This may result in a treatment plan that potentially irradiates the incorrect patient location if the error is not detected by users.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Elekta, Inc. or your healthcare provider for instructions. Notification method: Letter
About This Product
The Leksell GammaPlan is a specialized software system used for planning treatments with the Gamma Knife, a device for delivering targeted radiation therapy. Healthcare providers purchase this software to enhance the precision and effectiveness of radiation treatments for patients with various conditions.
Why This Is Dangerous
The hazard stems from an error in the software that allows users to inadvertently use an obsolete reference for treatment planning. If this happens, the software can generate a treatment plan that targets the wrong location on a patient, which could lead to severe health consequences.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall creates an urgent need for healthcare providers to stop using the affected version of the software, impacting treatment continuity. Patients may experience delays in their treatment planning until a safe version of the software is implemented.
Practical Guidance
How to identify if yours is affected
- Check the software version to confirm if it is 11.1.
- Verify if your system's Lot Code matches 07340048311236.
- Review any notifications from Elekta regarding the software.
Where to find product info
You can find the software version and Lot Code in the software's settings or about menu.
What timeline to expect
Expect a refund or replacement processing timeline of 4-8 weeks after the recall instructions are followed.
If the manufacturer is unresponsive
- Document all communications with Elekta regarding the recall.
- Contact your healthcare provider for assistance.
- File a complaint with the FDA if no response is received.
How to prevent similar issues
- Always verify software updates before use.
- Regularly check for recalls on medical devices and software.
- Ensure training for healthcare providers on software usage and updates.
Documentation advice
Keep records of your purchase, any communications regarding the recall, and your treatment plans.
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Product Details
The recall involves the Leksell GammaPlan Radionuclide RT Treatment Planning System, Software Version 11.1. The device is used for Leksell Gamma Knife treatment planning. The software is distributed worldwide including all U.S. states.
Key Facts
- Recall date: December 12, 2025
- Software version affected: 11.1
- Class II recall
- Global distribution including U.S. and multiple countries
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Safety Guide
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